EP3603576B1 - Perkutane herzklappenprothese - Google Patents

Perkutane herzklappenprothese Download PDF

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Publication number
EP3603576B1
EP3603576B1 EP19197203.3A EP19197203A EP3603576B1 EP 3603576 B1 EP3603576 B1 EP 3603576B1 EP 19197203 A EP19197203 A EP 19197203A EP 3603576 B1 EP3603576 B1 EP 3603576B1
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EP
European Patent Office
Prior art keywords
valve body
valve
prosthesis
catheter
percutaneous
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP19197203.3A
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English (en)
French (fr)
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EP3603576A1 (de
Inventor
Suku Thambar
Stayajit Rohan Jayasinghe
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Percutaneous Cardiovascular Solutions Pty Ltd
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Percutaneous Cardiovascular Solutions Pty Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2487—Devices within the heart chamber, e.g. splints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the present invention relates to a percutaneous heart valve prosthesis, and particularly relates to, but is not limited to, a percutaneous mitral valve prosthesis.
  • Heart valve regurgitation is a condition whereby the heart valve does not seal completely as a result of disease or injury, and may have fatal consequences.
  • Mitral valve replacement is firstly made difficult as a result of the anatomy of the mitral valve, and particularly that of the mitral valve annulus in which the mitral valve leaflets are located.
  • the mitral valve annulus is typically very distorted, and of unpredictable and non-uniform geometries, as compared to the relatively uniform aortic valve annulus. This unpredictable anatomy makes it difficult to design a pre-constructed mitral valve prosthesis that would fit the mitral valve annulus in a satisfactory manner for safe, stable and meticulous deployment.
  • the mitral valve annulus is bounded by muscular tissue on the outer wall only, with the inner side of the mitral valve annulus being bounded by a thin vessel wall which separates the mitral valve annulus and the aortic outflow tract.
  • the mitral valve annulus cannot be subjected to any significant radial forces, as would be typical with an expanding stent type of valve prosthesis, as such radial forces would tend to collapse the aortic outflow tract, resulting in circulatory collapse with likely fatal consequences.
  • firm anchoring of a deployed mitral valve prosthesis is currently not readily obtainable.
  • Mitral valve replacement techniques have also generally advocated removal of the native valve prior to location of the replacement mitral valve prosthesis. This is a technically extremely challenging task associated with the potentially fatal complication of profound mitral regurgitation that may not be adequately addressed by the subsequent valve replacement. The lack of an effective mitral valve may lead to overwhelming hemodynamic instability that may not be tolerated by the already compromised left ventricle and overwhelming pulmonary edema may rapidly result.
  • WO03037227 discloses a solution to anchor a prosthetic mitral valve using multiple lines extending from the prosthetic valve ring to the papillary muscle converging in two groups to two tubes, each comprising integral washers to position the tubes in relation to both the inside and outside of the ventricle of the patient's heart.
  • WO9930647 discloses another solution to anchor a prosthetic mitral valve using tension members between the valve ring and different points of the heart.
  • WO03003949 discloses an aortic valve having a valve body,an anchor device having a collapsible anchor frame and an anchor line line secured and extended between the valve body and the anchor frame.
  • a percutaneous heart valve prosthesis comprising:
  • the anchor device may comprise a collapsible anchor frame formed of elongate elastic anchor frame elements.
  • the anchor frame may be collapsible from a stable substantially flat plate-like configuration to an unstable elongate configuration for location within a catheter.
  • the anchor frame elements may each be formed of a superelastic shape memory material.
  • the valve body may comprise a collapsible valve body frame formed of elongate elastic valve body elements.
  • the valve body frame elements may each be formed of a superelastic shape memory material.
  • the valve body typically tapers toward said valve body first end.
  • the anchor line is then usually secured to said valve body first end.
  • the valve body frame may comprise at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid, each said deltoid having acute-angled vertices at said valve body first and second ends, and oblique-angled vertices located between said valve body first and second ends.
  • Each valve body sub-frame member may have the general form of a rhombus.
  • valve body sub-frame members may be joined at respective said oblique-angled vertices.
  • Each sub-frame member may further comprise a collapsible diagonal element extending between said oblique-angled vertices.
  • the one or more valve elements is/are generally secured to the diagonal elements.
  • the valve body frame may alternatively be in the general form of a collapsible cylindrical ring.
  • the prosthesis may further comprise a plurality of prongs spaced about a periphery of said valve body for engaging the native wall of a valve orifice in use.
  • the prosthesis may still further comprise a flexible skirt extending about a periphery of said valve body for blocking blood flow in said one direction between said valve body and the native wall of a valve orifice in use.
  • Said flexible skirt may be formed of biological material, typically pericardial material.
  • the prosthesis is typically a mitral valve prosthesis.
  • a percutaneous heart valve replacement system comprising:
  • a percutaneous heart valve prosthesis comprising:
  • the valve body may comprise a collapsible valve body frame formed of elongate elastic valve body elements.
  • the valve body frame elements may each be formed of a superelastic shape memory material.
  • the valve body frame may comprise at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid, each said deltoid having acute-angled vertices at said valve body first and second ends, and oblique-angled vertices located between said valve body first and second ends.
  • Each valve body sub-frame member may have the general form of a rhombus.
  • valve body sub-frame members may be joined at respective said oblique-angled vertices.
  • Each sub-frame member may further comprise a collapsible diagonal element extending between said oblique-angled vertices.
  • the one or more valve elements is/are generally secured to said diagonal elements.
  • the prosthesis is typically a mitral valve prosthesis.
  • a percutaneous heart valve replacement system comprising:
  • a percutaneous heart valve prosthesis comprising:
  • the flexible skirt may be formed of biological material, typically pericardial material.
  • the prosthesis is typically a mitral valve prosthesis.
  • a percutaneous heart valve replacement system comprising:
  • a percutaneous heart valve prosthesis in the form of a mitral valve prosthesis 1, comprises a valve body 2, first and second flexible valve elements 3, 4, an anchor device 5 and an anchor line 6 secured to and extending between the valve body 2 and the anchor device 5.
  • the valve body 2 has a first end 7 and a second end 8.
  • a blood flow passage 9 extends along a longitudinal axis 10 between the valve body first end 7 and the valve body second end 8.
  • the valve body 2 is configured so as to be collapsible about the longitudinal axis 10 to enable the valve body 2 to be located in a catheter for delivery of the prosthesis 1, as will be discussed further below.
  • the valve 2 is in the form of a collapsible valve body frame formed of elongate elastic valve body frame elements 11.
  • Each of the valve body frame elements 11 may be suitably formed as wires of a superelastic shape memory material.
  • a particularly suitable material is nitinol, a nickel-titanium alloy, which is known for use in percutaneous prosthesis applications.
  • Other suitable elastic metallic materials include stainless steel, gold, other titanium alloys and cobalt chromium molybdenum.
  • Other suitably rigid yet elastic metal alloys, or non-metallic materials may also be utilized as desired.
  • the valve body frame elements 11 will typically have a thickness of the order of 0.3 to 0.4 mm, however elements of varying diameter are also envisaged.
  • valve body frame 2 depicted in Figure 1 comprises three valve body sub-frame members 12.
  • One such valve body sub-frame member 12 is depicted in Figure 2 .
  • each valve body sub-frame member 12 is in the general form of a deltoid, and here particularly in the form of a diamond or rhombus (that is, a deltoid with four equal length sides).
  • Each valve body sub-frame member 12 is arranged such that the acute-angled vertices 13, 14 of the rhombus are arranged at the valve body first and second ends 7, 8, with the oblique-angled vertices 15, 16 located between the valve body first and second ends 7, 8.
  • Each valve body sub-frame member 12 will generally be formed of two wires, kinked to form the oblique-angled vertices 15, 16, with the ends of each wire being soldered to form the acute-angled vertices 13, 14, thereby providing the rhombus form.
  • the wires could be kinked to form the acute-angled vertices 13, 14, with the ends soldered at the oblique-angled vertices 15, 16.
  • Adjacent valve body sub-frame members 12 are joined at their respective oblique-angled vertices 15, 16 as depicted in Figure 1 , typically by soldering. Alternatively, the adjacent valve body sub-frame members may be sutured or joined by any other suitable means. Whilst, in the valve body 2 depicted, three sub-frame members 12 are joined so as to provide a generally triangular transverse cross-section, more than three sub-frame members may be utilised as desired such that the transverse cross-section of the valve body 2 becomes gradually more circular in shape with the addition of further body sub-frame members 12.
  • valve body 2 is arranged such that it tapers towards the valve body first end 7.
  • the valve body is tapered and sized such that the valve body first end 7 is able to pass through a mitral valve orifice associated with a mitral valve to be replaced, with the valve body second end 8 being sized so as not to pass through such a mitral valve orifice, when in the uncollapsed state.
  • a mitral valve orifice in an adult person typically has a diameter of the order of 25 mm.
  • each valve body sub-frame member 12 may further comprise a collapsible diagonal element 17 extending between the oblique-angled vertices 15, 16.
  • the diagonal elements will typically be in the form of a kinked wire formed of the same material as the remaining elements 11 of the valve body sub-frame member 12.
  • the kink is provided in the diagonal element 17 to enable it to readily collapse to allow delivery via catheter.
  • valve elements 3, 4, in the form of valve leaflets, are secured to the valve body 2 on opposing sides of the bloodflow passage 9.
  • the valve leaflets 3, 4 will be sutured to the diagonal elements 17 of the valve body sub-sub-frame members 12.
  • the valve leaflets 3, 4 are here overlapping, typically with a shorter leaflet 3 overlapped by a longer leaflet 4 lying between the shorter leaflet 3 and the valve body second end 8, such that, in use, the longer leaflet 4 lies on the outer or ventricular side of the valve body 2.
  • the valve leaflets 3, 4 are configured in a known manner so as to open toward the valve body second end 8, allowing bloodflow through the passage 9 in a direction from the valve body first end 7 toward the valve body second end 8, and to sealingly lock in response to pressure acting in the opposite direction, so as to block bloodflow through the passage 9 in the reverse or retrograde direction.
  • the valve leaflets may be formed of biological material, such as pericardial material, as is well known in the art, or of any other suitable flexible valve materials known in the art, including woven metallic materials or non-metallic materials such as silicone.
  • the valve leaflets may be sutured to the diagonal element 17 around the entire periphery of the passage 9, or may be hinged only at one or more discrete points around the periphery of the passage 9.
  • valve leaflet configurations may be utilised so as to provide the one way valve function required, including configurations utilising one valve leaflet only or utilising three or more valve leaflets as is known in the art.
  • a single valve element in the general form of a windsock might be utilised.
  • valve body 2 facilitates it being collapsed about the longitudinal axis 10, enabling it to fit within a catheter 18 for subsequent percutaneous deployment.
  • prongs typically in the form of barbs 19, may be spaced about the periphery of the valve body 2, typically at or adjacent the oblique-angled vertices 15, 16 of each sub-frame element, for engaging the native annular wall surrounding a valve orifice in use, as will be discussed below. Further barbs may be located at the acute-angled vertices 24 at the valve body second end 8. The barbs 19 will typically point toward the end 7, when the anchor line 6 is secured to the valve body first end 7.
  • a flexible skirt 20 may extend around the periphery of the valve body 2 for blocking retrograde bloodflow toward the valve body first end 7, between the valve body 2 and the native wall surrounding the mitral orifice in use.
  • the flexible skirt 20 will typically be sutured to the diagonal element 17 of each valve body sub-frame member 12, and as such will effectively provide a continuation of the valve leaflets 3, 4 on the exterior of the valve body 2.
  • the flexible skirt 20 may be formed of biological material, such as pericardial material, or alternatively might be formed of any suitable flexible non-biologic material, such as, for example, silicone, polyester or dacron.
  • the anchor device 5 will also typically comprise a collapsible anchor frame formed of elongate anchor frame elements 21.
  • the anchor frame elements 21 will again typically be formed of a superelastic shape memory material as per the valve body elements 11, and may again be formed of nitinol or other suitable elastic materials.
  • the anchor device frame 5 is formed of an array of anchor sub-frame members 22.
  • Each anchor sub-frame member has the general form of a rhombus. Rather than being joined side to side as per the valve body sub-frame members 12, however, the anchor sub-frame members 22 are here each joined in a radial pattern at their oblique-angled vertices 23, 24.
  • the anchor device 5 is collapsible from a stable substantially flat plate-like configuration (as depicted in Figures 6 and 7 ) to an unstable elongate configuration for location within a catheter 18 (as particularly depicted in Figure 8 ).
  • the anchor device 5 is provided at one end, corresponding to the oblique-angled vertices 23, with a coupling 25 for releasably coupling to a guide element as will be discussed below.
  • the coupling 25 may suitably be in the form of a threaded aperture.
  • the anchor line 6 will also generally be secured to the end of the anchor device 5 corresponding to the oblique-angled vertices 23, and will extend through the length of the anchor device 5 beyond the opposing oblique-angled vertices 24, such that tension applied to the anchor line 6 will tend to retain the anchor device 5 in the flat configuration.
  • the anchor line 6 may be formed of any suitable flexible wire or cord, and may be suitably formed again of nitinol wire or stainless steel wire. Other suitable materials may include carbon fibre, polyimides or aromatic polyamides. Where elasticity in the anchor line is desired, other suitable materials may include polyether block amide (PEBAX), silicone or polyurethane.
  • the opposing end of the anchor line 6 will typically be secured to the valve body first end 7, typically by way of three further lines 6a converging from the acute angled-vertices 13 of each-frame member 12 of the valve body 2. Where desired, further anchor lines 6 extending between the valve body 2 and anchor device 5 may be utilised.
  • the structure of the valve body 1 and anchor device 5 may be covered with biological material or less thrombogenic material to reduce the possibility of blood clotting around the non-biological material from which the valve body 2 and anchor device 5 will typically be formed.
  • a surgical procedure for replacement of a native mitral valve 101 utilising the prosthesis 1 will now be described with reference to Figures 9 to 15 .
  • measurements of the native mitral valve 101 and orifice 102 may be made with the use of a compliant balloon and transthoracic and transesophageal echocardiography.
  • the compliant balloon is located in the valve orifice 102 and expanded so as to move the leaflets of the native valve 101 out of the way and enable measurement of the diameter of the mitral valve orifice 102. A measurement of the distance between the native mitral valve 101 and the region of the inter-atrial septum 103 is also taken.
  • a suitably sized prosthesis valve body 2 is selected to fit the size of the mitral valve orifice 102 such that the valve leaflets 3, 4, will be positioned in the vicinity of the native valve 101.
  • the measurement of the distance between the native mitral valve 101 and the mid region of the inter-atrial septum 103 is also utilised to determine the length of the anchor line 6 extending between the valve body 2 and anchor device 5, such that the anchor line 6 will be taught when the prosthesis 1 is deployed, as will be discussed further below.
  • the venous system of the patient to be treated is accessed via a puncture 104, typically in the groin area, accessing the femoral vein 105. Access to the venous system might alternatively be made via other large peripheral veins such as the subclavian or jugular veins.
  • the femoral vein 105 is, however, preferred given the compressibility of the femoral vein 105 once a catheter is removed from the patient to achieve haemostasis.
  • a snare may be introduced to the heart 100 through an arterial approach from the left or right femoral artery, aorta and aortic valve. The snare will then engage a J-tip on the end of the guide wire 26 and draw the end of the guide wire 26 through the arterial system to the exterior of the patient so that opposing ends of the guide wire 26 may be steadied.
  • a catheter 18, typically having an internal diameter of at least 8 French (approximately 2.8 mm) is then advanced over the guide wire 26 and into the right atrium 107.
  • a puncture 108 is then made in the inter-atrial septum 103 using conventional equipment advanced via the catheter 18 in the known manner.
  • the guide wire 26 and catheter 18 are then further advanced through the septal puncture 108 into the left atrium 109, through the native mitral valve 101 and into the left ventricle 110 as shown in Figure 11 .
  • the first end 27 of the catheter 18 is thus located in the left ventricle 110 whilst the opposing second end of the catheter 18 is still located on the exterior of the patient.
  • the mitral valve prosthesis 1 is then collapsed and fed into the second end of the catheter 18, with the second end 8 of the collapsed valve body 2 leading.
  • An elongate prosthesis guide element 29 is detachably attached to the prosthesis 1, here by way of the screw threaded coupling 25 of the anchor device 5.
  • the prosthesis guide element 29 may be a further guide wire with a cooperating screw threaded coupling 30 on its end, or alternatively might be a narrower catheter.
  • the prosthesis 1 is advanced along the catheter 18 toward the catheter first end 27 as shown in Figure 12 . Rather than using a screw threaded coupling arrangement 25, 30 to couple the anchor device 25 and prosthesis guide element 29, a clip, clamp or the like may be utilised.
  • the prosthesis 1 is advanced until the valve body 1 is released past the catheter first end 27 and into the left ventricle 110 as shown in Figure 13 .
  • the elasticity of the valve body frame results in the valve body 2 extending to its uncollapsed state.
  • the valve body 2 remains attached to the anchor device 5 by way of the anchor line 6.
  • the catheter 18 is then withdrawn through the puncture 108 such that the catheter first end 27 is located in the right atrium 107.
  • the prosthesis guide element 29 is withdrawn so as to draw the expanded valve body 2 toward the native mitral valve orifice 102 and left atrium 109.
  • the valve body first end 7 is sized to enable it to pass through the mitral valve orifice 102
  • the valve body 2 is tapered such that the valve body second end 8 is sized so as not to pass through the mitral valve orifice 102
  • the valve body 2 engages the annular wall 111 of the mitral valve orifice and thus becomes wedged within the valve orifice 102.
  • valve body diagonal elements 17 and valve leaflets 3, 4 are ideally positioned adjacent the native mitral valve 101, whose leaflets are pushed away and crushed against the mitral valve orifice wall 111 by the valve body 2. Accordingly, with the native mitral valve 101 being pushed away from the mitral valve orifice 102, there is no need to remove the native mitral valve 101.
  • the peripheral skirt 20 extending about the valve body 2 is located on the ventricular side of the mitral valve orifice 102, so as to seal between the periphery of the valve body 2 and the mitral valve orifice wall 111 when the left ventricle 110 contracts and pressurises during ventricular systole.
  • the catheter 18 is then further retracted such that the anchor device 5 is released from the catheter first end 27.
  • the anchor device 5 As the anchor device 5 is released it expands to its uncollapsed state and, with appropriate sizing of the anchor line 6, engages the inter-atrial septum 103 from within the right atrium 107, as shown in Figure 15 .
  • the catheter 18 and guide wire 26 are then drawn back through the venous system and removed from the patient to complete the procedure.
  • the anchor device 5 and valve body 2 may be retracted back into the catheter 18 and removed if any difficulties are encountered.
  • the anchor device 5 thus securely anchors the valve body 2 in the mitral valve orifice 102 against migration towards the left ventricle 110 during atrial systole, when the left atrium 109 contracts and pressurizes.
  • the tapered configuration of the valve body 2 effectively wedging the valve body 2 into the mitral valve orifice 102, anchors the valve body 2 against migration towards the left atrium 109 during ventricular systole.
  • the barbs 19 additionally anchor the valve body 2 against migration towards the left atrium 109.
  • the prosthesis guide element 29 is detached from the anchor device 5, by rotating the prosthesis guide element 29 to thereby decouple the threaded coupling.
  • the entire procedure may be performed under the guidance of fluoroscopy, transthoracic and transesophageal echocardiography in a known manner.
  • valve leaflets 3, 4 replace the function of the native mitral valve leaflets, allowing bloodflow from the left atrium 109 to the left ventricle 110 through the mitral valve orifice 102 and bloodflow passage 9 of the valve body 2 during atrial systole, whilst blocking retrograde flow from the left ventricle 110 to the left atrium 109 during ventricular systole.
  • the peripheral skirt 20 further blocks bloodflow through any gaps between the valve body 2 and the mitral valve orifice wall 111 in the retrograde direction during ventricular systole.
  • a further anchor device 5 might be utilised to anchor the valve body 2 to the inter-ventricular septum 112.
  • the tapered form of the valve body 2 might be utilised in conjunction with other mechanisms for securing the valve body 2 against migration towards the left ventricle rather than utilising the anchor device.
  • the general valve prosthesis configuration may be utilised for other types of heart valve prosthesis, for replacement of the aortic semiluminar valve, pulmonary semiluminar valve or tricuspid valve, utilizing alternative structures of the heart for securing the anchor device.
  • valve prosthesis 201 An alternate form of valve prosthesis 201 is depicted in Figures 16 to 20 .
  • the prosthesis 201 has an anchor device 5 much the same as that of the prosthesis 1 of Figure 1 , however the valve body 202 is in the general form of a collapsible cylindrical ring.
  • the collapsible ring 202 is formed of a squat cylinder and may have a woven construction formed of elongate elastic elements, typically metallic wire. Again, a particularly suitable material is a superelastic shape memory material such as nitinol.
  • the valve body ring 202 should be sized so as to have an undeformed diameter slightly larger than that of the mitral valve orifice 102, such that when deployed, a compressive force is applied to the wall 111 of the valve orifice 102 to assist retaining the valve body in place. Care should be taken, however, not to oversize the valve body ring 202 such that an excessive compressive force is applied to the mitral valve orifice wall 111 which, as discussed above, may result in collapsing of the aortic outflow tract.
  • valve body ring 202 is arranged such that it may be collapsed into a cylindrical shape of reduced diameter, enabling it to be loaded into a catheter 18, as depicted in Figure 18 in a similar manner to the valve body 2 described above.
  • Valve leaflets 3, 4, as described above in relation to the first prosthesis 1, are secured to the valve body ring 202, again typically by suturing.
  • three anchor lines 6 secure the valve body ring 202 to the anchoring device 5, with the anchor line 6 being secured at points spaced equidistantly about the valve body ring 202.
  • Prongs 19 protrude from the valve body ring 202 toward the anchoring device 5 for engaging the valve orifice wall 111 in much the same manner as discussed above.
  • deployment of the prosthesis 201 is generally the same as that described above in relation to the first prosthesis 1, with the primary difference being the lack of a tapered body that is wedged into the mitral valve orifice 102 to assist anchoring against migration towards the left atrium 109.
  • the valve body ring 202 thus relies on the barbs 19 and compressive force applied to the mitral valve orifice wall 111 to prevent migration towards the left atrium 109.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Claims (14)

  1. Eine perkutane Herzklappenprothese (1), die Folgendes beinhaltet:
    einen Klappenkörper (2) mit einem ersten Klappenkörperende (7), einem zweiten Klappenkörperende (8) und einem Durchgang (9), der sich entlang einer Längsachse (10) zwischen dem ersten Klappenkörperende (7) und dem zweiten Klappenkörperende (8) erstreckt, wobei der Klappenkörper (2) zur Zuführung über einen Katheter (18) um die Längsachse (10) kollabierbar ist;
    ein oder mehrere flexible Klappenelemente (3, 4), die an dem Klappenkörper (2) befestigt sind, wobei das eine oder die mehreren flexiblen Klappenelemente (3, 4) sich über den Durchgang (9) erstrecken, um den Blutfluss in einer Richtung durch den Durchgang (9) zu blockieren;
    eine Ankervorrichtung (5), die einen kollabierbaren Ankerrahmen umfasst; und
    eine Ankerleine (6), die an dem Klappenkörper (2) und der Ankervorrichtung (5) befestigt ist und sich zwischen diesen erstreckt,
    dadurch gekennzeichnet, dass sie ferner drei weitere Leinen (6a) beinhaltet, wobei ein erstes Ende jeder weiteren Leine (6a) an dem ersten Klappenkörperende (7) befestigt ist, wobei ein zweites Ende jeder weiteren Leine (6a) auf die Ankerleine (6) zuläuft und an dieser befestigt ist.
  2. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei der Klappenkörper (2) aus Nitinol hergestellt ist.
  3. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei der Klappenkörper (2) eine Vielzahl von länglichen elastischen Klappenkörper-Rahmenelementen (11) umfasst.
  4. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei der Klappenkörper (2) sich von dem ersten Ende (7) zu dem zweiten Ende (8) erweitert, wobei das erste Ende (7) so dimensioniert ist, dass es durch eine Klappenöffnung (102), die mit einer zu ersetzenden Herzklappe (101) assoziiert ist, hindurchgeht und das zweite Ende (8) so dimensioniert ist, dass es in einem nicht kollabierten Zustand nicht durch die Klappenöffnung (102) hindurchgeht.
  5. Perkutane Mitralklappenprothese (1) nach Anspruch 1, die ferner eine flexible Schürze (20) beinhaltet, die sich um eine Begrenzungsfläche des Klappenkörpers (2) erstreckt, um im Gebrauch den Blutfluss in dieser einen Richtung zwischen dem Klappenkörper (2) und der nativen Wand einer Klappenöffnung (102) zu blockieren.
  6. Perkutane Mitralklappenprothese (1) nach Anspruch 5, wobei die flexible Schürze (20) aus Perikardmaterial, Silikon, Polyester oder Dacron hergestellt ist.
  7. Perkutane Mitralklappenprothese (1) nach Anspruch 5, wobei die flexible Schürze (20) an den Klappenkörperrahmen (2) angenäht ist.
  8. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei das eine oder die mehreren flexiblen Klappenelemente (3, 4) Perikardmaterial umfassen.
  9. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei das eine oder die mehreren flexiblen Klappenelemente (3, 4) drei Klappensegel umfassen.
  10. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei die Ankervorrichtung (5) einen kollabierbaren Ankerrahmen beinhaltet.
  11. Perkutane Mitralklappenprothese (1) nach Anspruch 10, wobei der kollabierbare Ankerrahmen eine flache, tellerähnliche Konfiguration und eine längliche Konfiguration aufweist.
  12. Perkutane Mitralklappenprothese (1) nach Anspruch 1, wobei die Ankerleine (6) Nitinoldraht, Edelstahldraht, Kohlenstofffaser, Polyimid, aromatisches Polyamid, Polyetherblockamid, Silikon oder Polyurethan beinhaltet.
  13. Perkutane Herzklappenprothese (1) nach Anspruch 1, wobei die Prothese (1) eine perkutane Mitralklappenprothese (1) ist.
  14. Ein System zum Ersetzen einer Mitralklappe (1), das Folgendes beinhaltet: die perkutane Herzklappenprothese (1) nach Anspruch 1, einen Zuführkatheter (18) mit einem ersten Katheterende (27) und einem zweiten Katheterende, wobei die perkutane Herzklappenprothese (1) in einem radial kollabierten Zustand in den Katheter (18) geladen und zu dem ersten Katheterende (27) hin positioniert werden kann; und ein längliches Führungselement (29), das ein erstes Führungselementende und ein zweites Führungselementende aufweist, wobei das erste Führungselementende abnehmbar an der Prothese (1) angebracht ist und das zweite Führungselementende sich über das zweite Katheterende hinaus erstreckt.
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US55197604P 2004-03-11 2004-03-11
PCT/AU2005/000346 WO2005087140A1 (en) 2004-03-11 2005-03-11 Percutaneous heart valve prosthesis
EP17200021.8A EP3308744B2 (de) 2004-03-11 2005-03-11 Perkutane herzklappenprothese
EP11152095.3A EP2308425B2 (de) 2004-03-11 2005-03-11 Perkutane Herzklappenprothese
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EP11152095.3A Division EP2308425B2 (de) 2004-03-11 2005-03-11 Perkutane Herzklappenprothese
EP11152095.3A Division-Into EP2308425B2 (de) 2004-03-11 2005-03-11 Perkutane Herzklappenprothese
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US20190159896A1 (en) 2019-05-30

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